Catalog Number

-

Brand Name

Omnipod DASH Pod

Version/Model Number

POD-BLE-11-520

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180045,K180045,K180045,K180045

Product Code

LZG

Product Code Name

Pump, Infusion, Insulin

Public Device Record Key

9c3a70fa-e8a8-4ee0-8c96-000616ba7246

Public Version Date

September 12, 2018

Public Version Number

2

DI Record Publish Date

August 01, 2018

Package DI Number

20385082000020

Quantity per Package

10

Contains DI Package

10385082000023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 Pack Box